今天是:2019-06-25 星期二

富马酸比索洛尔(康忻)治疗冠心病病人后静息心率水平与预后之间的关系研究
下载XML文档

注册号:

Registration number:

ChiCTR-OPN-15007091 

最近更新日期:

Date of Last Refreshed on:

2016-03-08 

注册时间:

Date of Registration:

2015-07-21 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

富马酸比索洛尔(康忻)治疗冠心病病人后静息心率水平与预后之间的关系研究 

Public title:

A study to investigate the association between resting heart rate (HR) prognosis of patients with Coronary Artery Disease (CAD) treated with bisoprolol 

注册题目简写:

Biso-CAD研究 

English Acronym:

Biso-CAD study 

研究课题的正式科学名称:

富马酸比索洛尔(康忻)治疗冠心病病人后静息心率水平与预后之间的关系研究 

Scientific title:

A study to investigate the association between resting heart rate (HR) prognosis of patients with Coronary Artery Disease (CAD) treated with bisoprolol 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

范新丽 

研究负责人:

陈韵岱 

Applicant:

Xinli Fan 

Study leader:

Yundai Chen 

申请注册联系人电话:

Applicant telephone:

+86 10-59072569 

研究负责人电话:

Study leader's telephone:

+86 13311119778 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

cindy.fan@merck.com 

研究负责人电子邮件:

Study leader's E-mail:

cyundai@vip.163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市朝阳区建国路91号金地中心B座10层 

研究负责人通讯地址:

北京市复兴路28号 

Applicant address:

18F, Tower B, Gemdale Plaza, 91 Jianguo Road, Chaoyang District, Beijing, China 

Study leader's address:

28 Fuxing road, Beijing (Wukesong) 

申请注册联系人邮政编码:

Applicant postcode:

100022 

研究负责人邮政编码:

Study leader's postcode:

100022 

申请人所在单位:

默克雪兰诺有限公司 

Applicant's institution:

Merck Serono Co., Ltd 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

[2011]临审第(047)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

解放军总医院药物临床试验伦理委员会 

Name of the ethic committee:

independent ethic committee of PLA hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-08-24 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

解放军总医院心内科 

Primary sponsor:

Cardiovascular Department of Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市复兴路28号 

Primary sponsor's address:

28 Fuxing road, Beijing (Wukesong) 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国人民解放军总医院

具体地址:

北京市复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing road, Beijing (Wukesong)

经费或物资来源:

默克学兰诺有限公司 

Source(s) of funding:

Merck Serono Co., Ltd 

研究疾病:

冠心病 

Target disease:

Coronary Artery Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

主要目的: 1. 证实口服Concor治疗冠心病患者18个月后,不同的静息心率水平与复合心脏事件(心血管死亡、非致死性心肌梗死和因不稳定型心绞痛或血运重建而住院)之间存在关联。 次要目的: 2. 评价口服Concor?治疗冠心病患者后,与基线水平相比6个月和18个月后心功能的改善情况,以及不同静息心率水平与心功能之间的关联; 3. 评价口服Concor?治疗冠心病患者后,与基线水平相比12个月和18个月后动脉粥样硬化的进展,以及不同静息心率水平与动脉粥样硬化进展之间的关联。 4. 评价口服Concor?治疗冠心病患者18个月后,不同静息心率水平分别与每一件心脏事件(全因死亡、心血管死亡、因ACS而住院和因血运重建而住院)之间的关联。 

Objectives of Study:

Primary Objective: To demonstrate the association between different resting HR the composite cardiac clinical outcomes (i.e. cardiovascular death, non-fatal acute myocardial infarction hospital admission for unstable angina or revascularization) in CAD patients treated with 18-month Concor. Secondary objectives: 1. To evaluate the change of heart function at baseline versus the 6th month the 18th month of study assessment, the association between different HR heart function in CAD patients treated with Concor; 2. To evaluate the development of atherosclerosis at baseline versus the 12th month the 18th month of study assessment, the association between different HR the development of atherosclerosis in CAD patients treated with Concor; 3. To evaluate the association between different HR each of the defined clinical outcomes (i.e. all-cause mortality, cardiovascular death, hospital admission for acute coronary syndrome coronary revascularization) in CAD patients treated with 18-month Concor. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

入组标准 1. 年龄:≥20岁 2. 稳定型心绞痛或不稳定型心绞痛的冠心病患者,伴随糖尿病或≥3个冠心病危险因素(男性≥55岁或女性≥65岁,高血压,血脂异常,吸烟,冠心病家族史,肥胖) 3. 静息心率≥70次/分钟; 4. 已签署知情同意书。 5. 已使用或处方康忻? 

Inclusion criteria

1. Patients aged >=20 years old; 2. CAD patients with stable or unstable angina (UA), accompanied with diabetes or possess >=3 risk factors (Males aged >=55 years or females aged >=65 years, hypertension, dyslipidemia, smoking, CAD family history, obesity); 3. Office resting heart rate >=70 beats/min; 4. Patients who have signed informed consent; 5. Concor was used or prescribed before enrollment. 

排除标准:

1. 具有康忻说明书中所列禁忌症的患者: a) 急性心力衰竭或处于心力衰竭失代偿期需用静注正性肌力药物治疗的患者 b) 心源性休克者 c) 二度或三度房室传导阻滞者(未安装心脏起搏器) d) 病窦综合征患者 e) 窦房阻滞者 f) 引起症状的心动过缓者(有症状的心动过缓) g) 有症状的低血压 h) 严重支气管哮喘或严重慢性阻塞性肺部疾病患者 i) 严重的外周动脉闭塞疾病和雷诺氏综合征患者 j) 未经治疗的嗜铬细胞瘤患者 k) 代谢性酸中毒患者 l) 已知对比索洛尔及其衍生物或本品任何成分过敏的患者 2. 具有以下情况的患者: a) 最近1个月内曾患急性心肌梗死的患者 b) 急性心肌炎 c) 严重的或未控制的高血压患者(SBP>180 mm Hg或舒张压>110 mm Hg) d) 严重心力衰竭患者(NYHA Ⅲ或Ⅳ) e) 伴有肝、肾功能异常者(按当地实验室测定标准): ? 谷丙转氨酶≥正常上限的2 倍 ? 谷草转氨酶≥正常上限的2倍 ? 血清肌酐≥正常上限的2倍 f) 研究者认为不适合参加该试验的任何其它情况 3. 已接受如下治疗的患者: a) 冠脉造影证实单支冠脉病变,且已完全血管重建的患者 b) 植入心脏起搏器或埋藏式心律转复除颤器的患者 4. 预期将需要如下处理的患者: a) 由于心脏瓣膜疾病所致可能在未来3年内需行外科手术的患者 b) 需要新增影响心率的药物或对其进行剂量调整,如依伐布雷定,非二氢吡啶类钙离子 5. 未严格避孕的育龄期妇女,怀孕及哺乳的妇女 6. 在研究中配合不好,无法或不愿签署知情同意书 7. 不具有法律能力或法律能力受到限制 

Exclusion criteria:

1. Patients with contra-indications to Concor? as defined in the insert sheet of Concor: (1) Acute heart failure or during episodes of heart failure decompention requiring i.v. inotropic therapy; (2) Cardiogenic shock; (3) Second or third degree AV block (without a pacemaker); (4) Sick sinus syndrome; (5) Sinoatrial block; (6) Symptomatic bradycardia; (7) Symptomatic hypotension; (8) Severe bronchial asthma or chronic obstructive pulmonary diseases; (9) Severe peripheral arterial occlusive diseases Raynauds syndrome; (10) Untreated pheochromocytoma; (11) Metabolic acidosis; (12) Known allergy to any components of Concor its derivatives. 2. Patients with the following conditions/events: (1) Acute myocardium infarction (AMI) in the preceding 1 month; (2) Active myocarditis; (3) Severe or uncontrolled hypertension (tolic blood pressure [SBP] >180 mm Hg or diastolic blood pressure [DBP] >110 mm Hg); (4) Severe chronic heart failure (New York Heart Association class III or IV); (5) Impaired hepatic or renal function (according to local lab standard): 1) Serum alanine aminotransferase (ALT) > twice of the normal valueper limit; 2) Serum Aspartate Aminotransferase (AST) > twice of the normal valueper limit; 3) Serum creatinine > twice of the normal valueper limit; (6) Other incompatible condition which judged by investigators. 3. Patients who had received the following: (1) Complete revascularization for a single coronary artery disease confirmed by coronary angiography (2) Implanted pacemaker or implantable cardioverter defibrillator. 4. Patients who are anticipated to require: (1) Surgery for valvular disease over the next 3 years; (2) New addition or doge adjustment of the drugs which can affect heart rate, for example nondihydropyridine Calcium Channel Blockers (CCBs) like verapamil or diltiazem, ivabradine, over the course of the trial. 5. Women of childbearing age without effective contraception measures, or who are pregnant or lactating; 6. Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent; 7. No legal ability legal ability is limited. 

研究实施时间:

Study execute time:

From2011-10-26To 2015-07-21 

干预措施:

Interventions:

组别:

1

样本量:

902

Group:

1

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京军区总医院 

单位级别:

三级甲等 

Institution
hospital:

General Hospital of Beijing Military Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属安贞医院 

单位级别:

三级甲等 

Institution
hospital:

Anzhen Hospital Affiliated to Capital Medicine University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

川北医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital to North Sichuan Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Chaoyang Hospital affliated to Capital Medicine University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Dalian Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中国人民武装警察部队总医院 

单位级别:

三级甲等 

Institution
hospital:

China Armed Police General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou First Peoples Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

中山 

Country:

China 

Province:

Guangdong 

City:

Zhongshan 

单位(医院):

中山市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan Peoples Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

湛江 

Country:

China 

Province:

Guangdong 

City:

Zhanjiang 

单位(医院):

广东医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Guangdong Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

首都医科大学附属北京复兴医院 

单位级别:

三级 

Institution
hospital:

Beijing Fuxing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou First Peoples Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

中南大学湘雅医院 

单位级别:

三级甲等 

Institution
hospital:

Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

中南大学湘雅二院 

单位级别:

三级甲等 

Institution
hospital:

The Second Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shaanxi 

City:

Xian 

单位(医院):

西京医院 

单位级别:

三级甲等 

Institution
hospital:

Xijing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shaanxi 

City:

Xian 

单位(医院):

唐都医院 

单位级别:

三级甲等 

Institution
hospital:

Tangdu Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

宣武医院 

单位级别:

三级甲等 

Institution
hospital:

Xuanwu Hospital  

Level of the institution:

Tertiary A hospital 

国家:

韩国 

省(直辖市):

Anyang 

市(区县):

Anyang 

Country:

Korea 

Province:

Anyang 

City:

Anyang 

单位(医院):

Hallym University Sacred Heart Hospital 

单位级别:

top 

Institution
hospital:

Hallym University Sacred Heart Hospital  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

首尔 

市(区县):

首尔 

Country:

Korea 

Province:

Seoul 

City:

Seoul 

单位(医院):

Samsung Medical Center 

单位级别:

top 

Institution
hospital:

Samsung Medical Center  

Level of the institution:

Samsung Medical Center 

国家:

韩国 

省(直辖市):

首尔 

市(区县):

首尔 

Country:

Korea 

Province:

Seoul 

City:

Seoul 

单位(医院):

Gangnam Severance Hospital 

单位级别:

top 

Institution
hospital:

Gangnam Severance Hospital  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

Bun 

市(区县):

Bun 

Country:

Korea 

Province:

Bun 

City:

Bun 

单位(医院):

Inje University Pun Paik Hospital 

单位级别:

top 

Institution
hospital:

Inje University Pun Paik Hospital  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

Daegu 

市(区县):

Daegu 

Country:

Korea 

Province:

Daegu 

City:

Daegu 

单位(医院):

Yeungnam University Medical Center 

单位级别:

top 

Institution
hospital:

Yeungnam University Medical Center  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

Cheonan 

市(区县):

Cheonan 

Country:

Korea 

Province:

Cheonan 

City:

Cheonan 

单位(医院):

Dan Kook University Hospital 

单位级别:

top 

Institution
hospital:

Dan Kook University Hospital  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

首尔 

市(区县):

首尔 

Country:

Korea 

Province:

Seoul 

City:

Seoul 

单位(医院):

Hallym University Medical Center 

单位级别:

top 

Institution
hospital:

Hallym University Medical Center  

Level of the institution:

top 

国家:

韩国 

省(直辖市):

Bucheon 

市(区县):

Bucheon 

Country:

Korea 

Province:

Bucheon 

City:

Bucheon 

单位(医院):

Sejong Hospital 

单位级别:

top 

Institution
hospital:

Sejong Hospital  

Level of the institution:

top 

国家:

越南 

省(直辖市):

胡志明市 

市(区县):

胡志明市 

Country:

Vietnam 

Province:

Ho Chi Minh City 

City:

Ho Chi Minh City 

单位(医院):

University Medical Center HCMC 

单位级别:

top 

Institution
hospital:

University Medical Center HCMC  

Level of the institution:

top 

国家:

越南 

省(直辖市):

胡志明市 

市(区县):

胡志明市 

Country:

Vietnam 

Province:

Ho Chi Minh City 

City:

Ho Chi Minh City 

单位(医院):

Tam Duc Hospital 

单位级别:

top 

Institution
hospital:

Tam Duc Hospital  

Level of the institution:

top 

测量指标:

Outcomes:

指标中文名:

复合心血管事件

指标类型:

主要指标 

Outcome:

composite cardiac clinical outcomes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标 

Outcome:

heart rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏彩超

指标类型:

次要指标 

Outcome:

echocardiography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈动脉超声

指标类型:

次要指标 

Outcome:

carotid artery ultrasound

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

no randomization

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-07-21
返回列表